Regulatory Affairs Specialist (MedTech/Pharma/Animal Health)

☞ HEMEX AG

Vue: 176

Jour de mise à jour: 26-03-2024

Localisation: Liestal Basel-Landschaft BL

Catégorie: Pharmacien / Représentants pharmaceutiques Ventes

Industrie:

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le contenu du travail

HEMEX AG is committed to changing the future of healthcare by guiding
the most promising European start-ups through each and every step to bring innovative pharmaceuticals, medical devices and in vitro diagnostics to the market. Headquartered close to the thriving Basel global Life Sciences hub, the goal at HEMEX is to ensure start-ups have access to a wide range of tailored products, practical solutions and fundraising support. This empowers the next generation of transformative discoveries to grow into successful and sustainable businesses, and drive change in both human and animal healthcare.

Tasks

The candidate will be joining our regulatory affairs group and will support expanding the team with additional regulatory affairs specialists as the company grows.

In this role the candidate will:
  • Act as an Subject Matter Expert regarding Regulatory Affairs (RA);
  • Provide interpretation of regulatory specific requirements to internal stakeholders;
  • Support our broad portfolio of start-ups with developing and implementing their
regulatory strategy to accelerate market access;
  • Frequent communication with clients, regulatory authorities, ethics committee and
institutional review boards in all continents;
  • Manage/coordinate various regulatory process, including CE-marking and Market Authorization Applications;
  • Support Sales Team with the preparation of cost proposals for clients;
  • Maintain and update existing regulatory authorizations and licenses;
  • Support with the maintenance of RA relevant regulations into Quality Management System
procedures, and support during certification audits by regulatory bodies;
  • Work with the multidisciplinary team to keep our clients informed of regulatory requirements and emerging issues which may affect the registration/approval of their products;
  • Able and willing to mentor other staff members;
  • Be (financial) results oriented for Hemex and its clients.
Requirements

The ideal candidate has experience in regulatory affairs for pharmaceuticals and/or medical devices, and is willing to develop into an all-round specialist for regulatory affairs in various industries (including animal health, cosmetics, environmental topics, …). In addition the candidate must have:

  • University degree in Medicine, Pharmacy, Life Sciences, or related discipline;
  • At least 3 years’ Regulatory Affairs experience in EU or US, in a regulated industry (pharmaceuticals, biologics, medical devices);
  • Good knowledge of international regulatory standards and regulations in the areas of quality, safety, and efficacy in the EU/US/CH, other regions are a plus;
  • Team player with strong interpersonal skills, excellent communicator;
  • Maturity, persuasiveness, and a high level of discretion;
  • Strong organizational skills with ability to multitask and independently set clear priorities;
  • Excellent problem-solving “can do” capacity;
  • Efficient working style and hands-on start-up mentality;
  • Excellent knowledge of MS Office tools (Word, Excel, Outlook, …);
  • Based in Northwestern Switzerland region;
  • Excellent in written and verbal English is a must;
  • Fluent in either German, French and/or Italian; other languages are an added benefit.
Benefits

  • Join a diverse, multi-disciplinary, highly motivated and skilled team working on a variety of medical innovations;
  • Office-based employment in Liestal (Switzerland), 7min by foot from Liestal SBB train station;
  • Modern, inclusive, pleasant working environment in a fast-growing, dynamic organization;
  • Ability to independently manage and develop your role and responsibilities.
If you meet the described profile, we look forward to receiving your application (Applications sent via e-mail will no
(in English).

Recruitment professionals: We only accept direct applications of qualified candidates. Requests from headhunters and job agencies will not be answered.
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Date limite: 10-05-2024

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